Warning

There is a higher chance of death in older adults who take Rexulti (brexpiprazole) for mental problems caused by dementia. Most of the deaths were
linked to heart disease or infection. This medicine is not approved to treat mental problems caused by dementia.

Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in
people who have had these thoughts or actions in the past. All people who take this medicine need to be watched closely. Call the doctor right
away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or
worse. Call the doctor right away if any thoughts or actions of suicide occur.

What do I need to tell my doctor BEFORE I take Rexulti?

If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what
signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check
to make sure that it is safe for you to take Rexulti with all of your drugs and health problems. Do not start, stop, or change the dose of
any drug without checking with your doctor.

What are some things I need to know or do while I take Rexulti?

Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.

Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Rexulti affects
you.

To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down
stairs.

High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These changes may raise the chance
of heart and brain blood vessel disease. Talk with the doctor.

Check your blood sugar as you have been told by your doctor.

Have blood work checked as you have been told by the doctor. Talk with the doctor.

Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.

Dizziness, sleepiness, and feeling less stable may happen with this medicine. These may lead to falling. Broken bones or other health problems
can happen from falling. Talk with the doctor.

Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of getting an infection. Deadly
infections have rarely happened. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have
signs of infection like fever, chills, or sore throat. Talk with your doctor.

Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these strokes have been deadly. This
drug is not approved to treat mental problems caused by dementia. Talk with your doctor.

If you are 65 or older, use Rexulti with care. You could have more side effects.

Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine
while you are pregnant.

Taking Rexulti in the third trimester of pregnancy may lead to muscle movements that cannot be controlled and withdrawal in the newborn.
Talk with the doctor.

Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Rexulti) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Take with or without food.

To gain the most benefit, do not miss doses.

Keep taking Rexulti as you have been told by your doctor or other health care provider, even if you feel well.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your
doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing;
tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue,
or throat.

Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or
breath that smells like fruit.

A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you
have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does
not feel normal, or are sweating a lot.

Some people who take this medicine may get a very bad muscle problem called tardive dyskinesia. This muscle problem may not go away even if
Rexulti (brexpiprazole) is stopped. Sometimes, signs may lessen or go away over time after this medicine is stopped. The risk of tardive dyskinesia may be
greater in people with diabetes and in older adults, especially older women. The risk is also greater the longer you take Rexulti or with
higher doses. Muscle problems may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling
body movements or if you have muscle problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering,
or chewing.

What are some other side effects of Rexulti?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical
help if any of these side effects or any other side effects bother you or do not go away:

Dizziness.

Feeling sleepy.

Feeling tired or weak.

Restlessness.

Headache.

Weight gain.

Nose and throat irritation.

Shakiness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical
advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was
taken, how much, and when it happened.

How do I store and/or throw out Rexulti?

Store at room temperature.

Store in a dry place. Do not store in a bathroom.

Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.

Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your
pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

If your symptoms or health problems do not get better or if they become worse, call your doctor.

Do not share your drugs with others and do not take anyone else's drugs.

Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.

Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.

This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is
refilled. If you have any questions about Rexulti, please talk with the doctor, pharmacist, or other health care provider.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was
taken, how much, and when it happened.

Disclaimer:
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the
knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe,
effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Rexulti.
It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that
may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare
provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Rexulti.